Recurrent Prostate Cancer
Conditions
Brief summary
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan. SECONDARY OBJECTIVES: I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done. II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan. III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline. IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI. OUTLINE: Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan. After completion of study, patients are followed up at 4-6 months and periodically until week 52.
Interventions
PROCEDUREcomputed tomography
Undergo CT
PROCEDUREbone scan
Undergo bone scan
PROCEDURE3-Tesla magnetic resonance imaging
Undergo axial MRI
PROCEDUREdiffusion-weighted magnetic resonance imaging
Undergo WB MRI
RADIATIONfluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT
PROCEDUREpositron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of prior radical prostatectomy for prostate cancer * Two PSA values \>= 0.2 ng/mL at least 4 weeks after prostatectomy * Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Exclusion criteria
* Patients with known metastatic disease * PSA recurrence not verified by elevated PSA as discussed in the eligibility section * Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Up to 12 months | Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography: Undergo CT
bone scan: Undergo bone scan
3-Tesla magnetic resonance imaging: Undergo axial MRI
diffusion-weighted magnetic resonance imaging: Undergo WB MRI
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis: Correlative studies | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) |
|---|---|
| Age, Continuous | 66 years |
| Race/Ethnicity, Customized African American | 4 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 34 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 4 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Time frame: Up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) | Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Positive CT Scan | 0 Participants |
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) | Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Positive Bone Scan | 0 Participants |
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) | Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Positive MRI | 12 Participants |
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) | Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Positive PET | 17 Participants |